Effect of Probiotics on Cardiometabolic Health

An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.

Study Overview

• Status: Completed
• Conditions: Cardiometabolic Risk Factors
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Placebo control

Detailed Description

Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.

However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • Department of Nutrition and Food Hygiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Local residents aged between 30-60 years old;
• Stable weight (<5% weight change over last 3 months);
• Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c <40 mg/dL (1.03 mmol/L) in males or <50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
• Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;
• Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.

Exclusion Criteria:

• Acute illness or current evidence of acute or chronic inflammatory of infective diseases;
• Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
• Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; Subjects are instructed to take one capsule of probiotics daily for a total of 3 months	Dietary supplement: Probiotics; During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
Placebo Comparator: Placebo Control; Subjects are instructed to take one capsule of placebo daily for a total of 3 months	Dietary supplement: Placebo control; During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow-mediated slowing (FMS)	FMS is a simple test for endothelial functions measured by Vicorder. In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced.	from baseline to 12 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut microbiota	Alterations of the composition of gut microbiota evaluated by metagenomics	from baseline to 12 weeks after intervention
microbial metabolites	alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry	from baseline to 12 weeks after intervention
Metabolic Syndrome Severity Z Score (MetZ score)	MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose). It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status.	from baseline to 12 weeks after intervention
Lipid profiles	alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser	from baseline to 12 weeks after intervention
Blood pressure	alterations of blood pressure	from baseline to 12 weeks after intervention
Insulin sensitivity	alterations of HOMA-IR index	from baseline to 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Pro-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No